FYFClass I
Cap, Surgical
21 CFR 878.4040 / General, Plastic Surgery
FYF is the FDA product code for Cap, Surgical, a class I device type, regulated under 21 CFR 878.4040. As of , FDA records hold 32 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- FYF
- Device name
- Cap, Surgical
- Regulation
- 21 CFR 878.4040
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 32
- Ingested recalls
- 0
Clearances, product code FYF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1977 | 3 |
| 1980 | 3 |
| 1981 | 1 |
| 1983 | 1 |
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 4 |
| 1988 | 5 |
| 1991 | 1 |
| 1996 | 6 |
| 1997 | 1 |
Applicants with the most clearances
Product code FYF| Applicant | Clearances |
|---|---|
| Amerasia Corp. | 3 |
| Sherwood Medical Industries | 3 |
| The Owenby Co. | 3 |
| A Plus International, Inc | 2 |
| American Threshold Industries, Inc. | 2 |
| Kimberly-Clark Corporation | 2 |
| American Convertors Div., American Pharmaseal | 1 |
| American Seal Co. | 1 |
| Anago, Inc. | 1 |
| Anago, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- 15445361 Canada Inc.
- Aimmax Medical Products Co.,Ltd.
- Alira Medical Devices LLC
- Allcare, Inc.
- Allmed Medical (Hubei) Protective Products Co., Ltd
- Alphaprotech, Inc.
- AM Nonwovens
- Amaryllis Healthcare Pvt. Ltd
- AMD Hubei Inc.
- AMD Medicom Inc.
- Amis (Xiamen) Cultural Creativity Co., Ltd
- Ammar Apparel II S. de R.L de C.V.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
